Document paper New medtech regulations

Clinical Evidence Requirements for CE certification under the in vitro Diagnostic Regulation in the European Union

The “Clinical Evidence Requirements for CE certification under the In vitro Diagnostic Regulation in the European Union” (First Edition May 2020, Second Edition November 2021) is a collection of questions and answers designed to help manufacturers navigate their performance evaluation obligations under the new IVD Regulation 2017/746.

These questions and answers are the results of the collective wisdom of many regulatory and clinical experts, members of MedTech Europe and authority representatives.

MedTech Europe is committed to supporting the IVD industry in successfully transitioning to the IVD Regulation. This publication is being put in the public domain so that manufacturers both within and outside our membership can efficiently transition to the new Regulation in an aligned and consistent manner.

Please see below the two editions of the “Clinical Evidence Requirements for CE certification under the In vitro Diagnostic Regulation in the European Union” MedTech Europe:

  1. Second Edition, published November 2021 (14 chapters) new
  2. First Edition, published May 2020 (10 chapters)

Posted on 28.05.2020

Related content